A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
- Conditions
- Cytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00002134
- Lead Sponsor
- Roche Global Development
- Brief Summary
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
- Detailed Description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Saint Clare's Prof Office
🇺🇸New York, New York, United States
Dr Neil Brourman
🇺🇸Beverly Hills, California, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Dr Michael Stewart
🇺🇸Jacksonville, Florida, United States
Vitreo - Retinal Consultants
🇺🇸New York, New York, United States
Univ of Kentucky Med Ctr
🇺🇸Lexington, Kentucky, United States
UCI College of Medicine
🇺🇸Irvine, California, United States
Estelle Doheny Eye Clinic
🇺🇸Los Angeles, California, United States
Dr Robert Avery
🇺🇸Santa Barbara, California, United States
Emory Eye Clinic
🇺🇸Atlanta, Georgia, United States
Dr David Weinberg
🇺🇸Chicago, Illinois, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
New England Med Ctr / Tufts Univ
🇺🇸Boston, Massachusetts, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Dr Alan Palestine
🇺🇸Washington, District of Columbia, United States
Bascom Palmer
🇺🇸Miami, Florida, United States
Univ of Washington Med Ctr
🇺🇸Seattle, Washington, United States
Dr Dorothy Friedberg
🇺🇸New York, New York, United States
New York Hosp
🇺🇸New York, New York, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Dr Robert T Wendel
🇺🇸Sacramento, California, United States
Kaiser Hosp
🇺🇸San Francisco, California, United States